Manager, Legal Firm

Employer: Biolytical

Location: Richmond, British Columbia

Salary: $30.00 to $87.00 hourly

bio Lytical is hiring an experienced Regulatory Affairs (RA) Manager. You will be responsible for defining and implementing regulatory strategies to obtain global approvals for new/modified devices to meet bio Lytical's corporate objectives. This role requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as US FDA, Health Canada and international Health Authorities. The Regulatory Affairs Manager is responsible for all product licensing and registration, medical device reporting, reviewing customer complaints, post-market surveillance, product labeling, and permissible marketing communication. HOW YOU WILL CONTRIBUTE Working closely with Executive Management, Sales and Marketing and Scientific Affairs to develop the regulatory strategy to gain market approval for new or modified devices consistent with corporate objectives Leading the preparation of complex